Eli Lilly's Covid-19 antibody drug treatment gets emergency USFDA clearance
Eli Lilly & Co.’s antibody therapy was granted an
emergency-use authorisation by U.S. drug regulators for treating Covid-19,
widening access to a treatment that early data suggests is effective in keeping
people infected with the coronavirus out
of the hospital.
The
Food and Drug Administration authorised the experimental treatment, called
bamlanivimab, for use against mild-to-moderate Covid-19 in adults, including
those who are 65 and older, and pediatric patients, the agency said on its
website.
Shares
of the Indianapolis-based Lilly gained 4.5% in late trading on Monday. Through
the close, the stock had advanced 8.3% so far this year.
The
clearance gives doctors an option for tackling the virus in high-risk patients
before they’re sick enough to require hospitalisation. Other treatments that
received the regulatory go-ahead, such as convalescent plasma, a component
collected from the blood of recovered Covid patients containing immune factors,
and Gilead Sciences Inc.’s antiviral remdesivir, are intended for use in
severely ill Covid-19 patients.
Now
begins an even more difficult challenge: distribution. Lilly said in a
statement Monday that bamlanivimab should be administered “as soon as possible
after a positive Covid-19 test and within 10 days of symptom onset.” Lilly will
begin shipping the antibody therapy immediately to AmerisourceBergen Corp.,
which will distribute it as directed by the U.S. government. Americans will
have no out-of-pocket costs for the medicine, the company said, while
acknowledging that health-care facilities may charge a fee for the product’s
intravenous administration.
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